Trial · NCT01242813
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete or Almost Complete Response at Day 15 | Day 15 | The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment for primary efficacy. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete or Almost Complete Response at Day 8 | Day 8 | The analysis was performed on the FAS population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Clinical Remission at Day 8 and 15 | Day 8 and Day 15 | The analysis was performed on the FAS population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15 | Day 8 and Day 15 | The analysis was performed on the FAS population. | Percentage of participants | NUMBER |
| SECONDARY | Time to Physician's Assessed Clinical Remission | Baseline up to Day 15 | The analysis was performed on the FAS population. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8 | Day 15 | The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Time to Participant's Assessed Clinical Remission | Baseline up to Day 15 | The analysis was performed on the FAS population. | Days | MEDIAN |
| SECONDARY | Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study | Day 1 up to Day 953 (End of study) | The analysis was performed on the FAS population. | Percent change | MEDIAN |
| SECONDARY | Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain | Day 113 (end of treatment period) up to Day 925 (End of study) | The analysis was performed on the FAS population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Defined Grades in Physician's Global Assessment Score | Day 1 up to Day 953 (End of study) | The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Defined Grades in Participant's Global Assessment Score | Day 1 up to Day 253 (End of follow-up period) | The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Relapsed Participants | Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449,477,505, 533, 561, 589, 617, 645, 673,701, 729,757, 785, 813, 841,869, 897, 925 and 953 | The analysis was performed on the FAS population. | Percentage of participants | NUMBER |
| SECONDARY | Time to Relapse After Last Dose of Canakinumab | Day 85 to Day 253 (End of treatment period to Follow-up period) | The analysis was performed on the FAS population. | Days | MEDIAN |
| SECONDARY | Percentage of Participants Who Relapsed and Received Rescue Medication | Day 85 to Day 953 (End of treatment period to End of study) | The analysis was performed on the FAS population. | Percentage of participants | NUMBER |
| SECONDARY | Serum Concentration of Canakinumab | Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953 | The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | microgram(s)/milliliter | MEAN |
| SECONDARY | Serum Concentration of Total Interleukin-1β Antibody (IL-1β) | Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953 | The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | pg/mL | MEAN |
| SECONDARY | Number of Participants With Anti-canakinumab Antibodies at Any Visit | Day 1 up to Day 953 (End of study) | The analysis was performed on the FAS population. | Number of participants | NUMBER |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01242813/outcomes